The Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act HR 1221 / S 626

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1 The Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act HR 1221 / S 626 Introduced by US Reps. Renee Ellmers (R-NC) and Diana DeGette (D-CO); and US Sens. Chuck Grassley (R-IA) and Charles Schumer (D-NY) Staff Contacts: US Rep. Renee Ellmers: Adnan.Jalil@mail.house.gov; (202) US Rep. Diana DeGette: Polly.Webster@mail.house.gov; (202) US Sen. Chuck Grassley: Karen_Summar@Grassley.senate.gov; (202) US Sen. Charles Schumer: Veronica_Duron@Schumer.senate.gov; (202) As Congress considers options to modernize and strengthen the Medicare and Medicaid programs, the provisions of the common-sense, bipartisan Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act (HR 1221 / S 626) should be part of any discussion. The HELLPP Act would improve Medicare and Medicaid health outcomes, enhance patient choices, and actually reduce the federal budget deficit. The legislation would accomplish this by: 1. Recognizing podiatrists as physicians under Medicaid For more than 40 years, Medicare has defined doctors of podiatric medicine (DPMs, or podiatrists) as physicians. But this is not the case in Medicaid. Access to medical and surgical foot and ankle care provided by a podiatrist is considered optional and is not covered by all state plans, thus limiting Medicaid patient access to specialized foot and ankle medical and surgical care. The HELLPP Act would bring Medicaid in line with Medicare (and a majority of US health-care delivery systems) and ensure Medicaid patients have access to care by the best educated and trained providers of foot and ankle care. The legislation would not mandate new Medicaid services or benefits, nor would it require any Medicaid patient to seek care from a podiatric physician. It would not expand the scope of practice. It would simply provide that Medicaid patients have a full range of choices to see the physicians who are best trained for the foot and ankle care they seek. Podiatric physicians and surgeons are licensed by their state boards to prescribe medication and perform surgeries, and deliver independent medical and surgical care without any supervision or collaboration requirement. Evidence shows that when DPMs are delivering foot and ankle care, outcomes are better, hospitalizations fewer and shorter, and the health-care system saves billions of dollars annually. Podiatric physicians and surgeons are often included in prominent public and private benefits packages. The Federal Employees Health Benefits Program (FEHBP), available nationally to federal employees, is one prime example of a benefits package which covers foot and ankle care by podiatrists.

2 Under current law, foot and ankle care services are a covered benefit. However, when those services are provided by DPMs they can be teased out as optional coverage ( podiatry services ). This problem persists because podiatrists are not defined as physicians under Medicaid even though they have been defined as such under Medicare for more than 40 years. Currently, Medicaid effectively discriminates and can arbitrarily preclude patient access to a licensed and credentialed specialized physician class even though the services provided are covered benefits. Thus, Medicaid fails the basic tests of free market competition and patient choice. 2. Clarifying and improving coordination of care in Medicare's Therapeutic Shoe Program for patients with diabetes The current processes and Medicare contractor requirements for determining eligibility for Medicare s Therapeutic Shoe Program for patients with diabetes, and for furnishing this medically necessary benefit, are unnecessarily burdensome and frequently bogged down, leading to frustration on the part of the certifying physician, prescribing doctor, and supplier. The clarifications in the legislation would remove confusion and regulatory inconsistencies in the provision of this medically necessary benefit. They would allow each member of the collaborative team MD/DO, DPM, and supplier to work together more effectively and seamlessly on behalf of diabetic patients, resulting in less patient confusion, less provider frustration, and fewer office visits for the Medicare system. Specifically, the language would allow Medicare to conform with the real world of health-care delivery concerning how therapeutic shoes for diabetic patients are diagnosed, evaluated, and furnished. The clarifications would statutorily legitimize and recognize the prescribing podiatrist s (and other qualified physician s) lower-extremity examinations, determination of foot pathology, and the medical necessity for therapeutic shoes/inserts when making a case (to CMS and auditors) for qualifying Medicare s therapeutic shoe and insert benefit for their patients with diabetes. 3. Strengthening Medicaid program integrity through a fiscally responsible budget offset By closing a loophole that allows tax-delinquent Medicaid providers to still receive full Medicaid reimbursements, this provision will save the Medicaid system money and more than offset any additional federal budget costs associated with the recognition of podiatrists as physicians under Medicaid. Such a mechanism already exists in Medicare so this could save billions of dollars for the public health-care system. Under current law, Medicaid health-care providers who owe significant back taxes are still getting paid in full by Medicaid because of a loophole in the tax laws. The Government Accountability Office (GAO) conducted a study highlighting this irregularity, released July, 2012 (GAO ): Providers in Three States with Unpaid Federal Taxes Received over $6 Billion in Medicaid Reimbursements. This loophole has existed for a number of years, and several previous bipartisan bills have attempted to reform it. GAO estimates that the government could have recouped up to $330 million in uncollected taxes due in 2009 in three states alone if the legal mechanisms were in place for Medicaid the way they are in Medicare to offset public program payments for federal taxes owed. The net result of implementing the HELLPP Act s common-sense reforms would be significant improvements to patient access to quality foot and ankle care, and meaningful savings for Medicaid and other parts of our health-care delivery system.

3 ISSUE BRIEF The Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act Request The American Podiatric Medical Association (APMA) requests you cosponsor the Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act, introduced by US Reps. Renee Ellmers (R-NC) and Diana DeGette (D-CO) (H.R. 1221), and US Sens. Chuck Grassley (R-IA) and Charles Schumer (D-NY) (S. 626). Problem The current Medicaid (Title XIX) statute covers physician services, including in most cases medical and surgical care of the foot and ankle. However, the definition of a physician is limited to care provided by a medical doctor (MD) or doctor of osteopathy (DO) as defined in 1861(r) (1) of the Social Security Act (SSA). Podiatric Services, which are not specifically defined in Medicaid (Title XIX) but are presumed to mean services provided by a Doctor of Podiatric Medicine (DPM), are considered optional, despite the fact that podiatric physicians are educated, trained, and licensed to perform the same foot and ankle care services as MDs and DOs. Doctors of podiatric medicine have been defined in the Medicare statute [1861(r)(3), SSA] as physicians for more than 40 years and are covered as providers in nearly all other federal health programs, including TRICARE, the Veterans Health Administration (VHA), and the Indian Health Service. Background Essential medical and surgical foot and ankle care is covered as a benefit by Medicaid programs in all 50 states and the District of Columbia, but it is not always covered when provided by a doctor of podiatric medicine. Current law effectively limits Medicaid beneficiaries access to the quality, cost-effective services provided by podiatrists and discriminates against the type of licensed medical professional Medicaid patients might see for foot and ankle care. The Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act would save lives, limbs, and money for the Medicaid program for both states and the federal government. A higher-than-average percentage of Medicaid beneficiaries are at risk for diabetes and related lower limb complications. Thomson Reuters, which provides industry expertise and critical information to decision makers in financial, legal, tax and accounting, and health-care areas, conducted a three-year study (accessible at: that arrived at, among others, the following conclusions: trist prior to a foot ulcer diagnosis had a 20-percent lower risk of amputation and a 26-percent lower risk of hospitalization than those not seen by a podiatrist a 23-percent lower risk of amputation and a 9-percent lower risk of hospitalization compared with those not seen by a podiatrist each dollar invested in care by a podiatrist results in up to $51 of savings each dollar invested in care by a podiatrist results in up to $13 of savings. Treatment costs for diabetic foot ulcers range between $7,439 and $20,622 per episode. Estimated costs for a limb amputation are $70,434, and can cost as much as $500,000 over a lifetime. The potential and very significant cost savings of ensuring access to podiatric physicians in all sectors of the health care system including Medicaid cannot be disregarded. Strong Bipartisan & Outside Support Removing barriers for patient access to podiatric physicians has enjoyed strong bipartisan support in Congress, with bill language previously garnering 32 Senate cosponsors and 220 House cosponsors. It was included in the Senate Finance Committee s initial Chairman s mark of the Deficit Reduction Act of 2005 and in one of the major health reform proposals in 2009, and in the US Senate s main SGR reform bills. The provision has also received past support from a diverse group of health-care stakeholders including the National Hispanic Medical Association and the American Public Health Association. Cost The Congressional Budget Office (CBO) provided an estimate of the Medicaid portion of the bill in The score was $200 million over ten years, but did not examine savings that would result from the avoidance of unnecessary hospitalization or prevention of lower extremity amputations and assumed a greatly expanded Medicaid-eligible population. In 2014, CBO issued an updated score of the Medicaid and Medicare provisions, dramatically inflating its estimate to $1.3 billion over ten years. This estimate must be revisited because CBO mistakenly interpreted both provisions to be expansions of existing programs. Current Medicaid may deny patient access to the licensed and credentialed medical and surgical specialty care provided by podiatric physicians, even though the care they provide foot and ankle care is a covered benefit. The Helping Ensure Life- and Limb-Saving Acess to Podiatric Physicians (HELLPP) Act Prepared by the American Podiatric Medical Association, 9312 Old Georgetown Road, Bethesda, MD 20814, , Contact advocacy@apma.org with questions.

4 ISSUE BRIEF Podiatric Medicine: Doctors of podiatric medicine are podiatric physicians and surgeons, qualified by their education, training, and experience to diagnose and treat conditions affecting the foot, ankle, and related structures of the leg. cused on a specific part of the anatomy similar ophthalmology, cardiology, and otolaryngology. podiatrists can focus on specialty areas such as surgery, sports medicine, biomechanics, geriatrics, pediatrics, orthopedics, or primary care. Doctors of podiatric medicine have the education, training, experience, and licensure to: physical examinations; therapy; constructive surgery; studies. Podiatric Medical Education Doctors of podiatric medicine receive basic and clinical science education and training comparable to that of medical doctors: on life sciences atric medical colleges residency training The education, training, and experience podiatrists receive in the care and treatment of the lower extremity is more sophisticated and specialized than that of broadly trained medical specialists. Podiatric Medicine: Expertise in Foot and Ankle Care Comparison of Physician Education, Training and Practice Degree 4 Year Graduate Medical Education Minimum 3 Year Residency Independently Diagnose and Treat (Office) Independently Diagnose and Treat (Hospital) Surgical Privileges (Hospital) Admitting (H&P) Privileges Full Rx License Doctor of Podiatric Medicine (DPM) Medical Doctor (MD) Doctor of Osteopathic Medicine (DO) Prepared by the American Podiatric Medical Association, 9312 Old Georgetown Road, Bethesda, MD 20814, , Contact advocacy@apma.org with questions.

5 ISSUE BRIEF The Majority of Foot/Ankle Care in the U.S. is Performed by Podiatric Physicians but Medicaid Patients May Not Have Access For foot and ankle issues, most Americans seek out specialists for their care, typically a Doctor of Podiatric Medicine, an orthopedist, or other physician. The majority of medical care of the foot and ankle is performed by podiatrists. Even though foot and ankle care is generally a covered benefit under Medicaid, the program currently teases out a separate podiatry benefit as being optional for patients, focusing on the provider of services, rather than ensuring coverage of medically necessary care regardless of the qualified professional furnishing such care. Thus, Medicaid effectively discriminates and can arbitrarily preclude patient access to a licensed and credentialed specialized physician class even though the services they provide foot and ankle care are a covered benefit. Amputation of Toe Ankle Fracture Open Fix Bunion Surgery Hammertoe Repair Metatarsal Fracture Open Fix Remove Ingrown Nail Repair Achilles T endon Ulcer Debridement Source: Thomson Reuters Market Scan survey data for 2010 commercial health insurance claims Whenever public or private health insurance programs preclude patient access to podiatric physicians, there are adverse impacts on our health-care delivery system: 1. Costs increase by driving patients to a more expensive point of service (e.g., hospital emergency rooms) for the same services. 2. It exacerbates America s growing physician shortage by not appropriately utilizing the full range of physician specialists. 3. It denies patients the option of seeing the physicians who are best trained for the foot and ankle care they seek. COMMON FOOT & ANKLE PROBLEMS TREATED BY PHYSICIANS % PODIATRIC PHYSICIAN ORTHOPEDIST ALL OTHER The Majority of Foot/Ankle Care in the U.S. is Performed by Podiatric Physicians but Medicaid Patients May Not Have Access Prepared by the American Podiatric Medical Association, 9312 Old Georgetown Road, Bethesda, MD 20814, , Contact advocacy@apma.org with questions.

6 ISSUE BRIEF Fact Sheet: Studies Prove Podiatrists Prevent Complications, Provide Savings According to the CDC, nearly 26 million Americans live with diabetes. Diabetes is the leading cause of nontraumatic lower-limb amputation; however, amputations can be prevented. Two peer-reviewed published studies evaluated care by podiatrists for patients with diabetes and demonstrated that compared to other health-care professionals, podiatrists are best equipped to treat lower extremity complications from diabetes, prevent amputations, reduce hospitalizations, and provide savings to our health-care delivery systems. Access to a Podiatrist Can Lead to Savings for US Health-Care Delivery Systems According to a study conducted by Thomson Reuters Healthcare (accessible at: that compared outcomes of care for patients with diabetes treated by podiatrists versus care provided by other health-care professionals and physicians published in the Journal of the American Podiatric Medical Association 1 : savings of $19,686 per patient with diabetes can be realized over a three-year period if there is at least one visit to a podiatrist in the year preceding a diabetic ulceration. Diabetic ulcerations are the primary factor leading to lower extremity amputations. Among patients with commercial insurance, each $1 invested in care by a podiatrist results in $27 to $51 of savings for the health-care delivery system. $4,271 per patient with diabetes can be realized over a three-year period if there is at least one visit to a podiatrist in the year preceding ulceration. Among Medicare eligible patients, each $1 invested in care by a podiatrist results in $9 to $13 of savings. bers support an estimated $10.5 billion in savings over three years if every at-risk patient with diabetes sees a podiatrist at least one time in the year preceding the onset of an ulceration. Care by a Podiatrist Can Reduce the Risks and Prevent Complications from Diabetes According to an independent study conducted by Duke University published in Health Services Research 2 : likely to experience a lower extremity amputation if a podiatrist was a member of the patient-care team. who only saw a podiatrist experienced a lower risk of amputation compared with patients who did not see a podiatrist. podiatrists most effectively prevents complications from diabetes and reduces the risk of amputations. Fact Sheet: Studies Prove Podiatrists Prevent Complications, Provide Savings 1 Ginger Carls et al., The Economic Value of Specialized Lower-Extremity Medical Care by Podiatric Physicians in the Treatment of Diabetic Foot Ulcers, Journal of the American Podiatric Medical Association 101 (2011): , accessible at: 2 Sloan, F. A., Feinglos, M. N. and Grossman, D. S., RESEARCH ARTICLE: Receipt of Care and Reduction of Lower Extremity Amputations in a Nationally Representative Sample of U.S. Elderly. Health Services Research, no. doi: Prepared by the American Podiatric Medical Association, 9312 Old Georgetown Road, Bethesda, MD 20814, , Contact advocacy@apma.org with questions.

7 HOLES IN THE SAFETY NET WA OR NV CA ID AZ UT MT WY CO NM ND SD NE KS OK MN WI IA IL MO AR MS VT NY MI PA OH IN WV VA KY NC TN SC AL GA ME NH MA RI CT NJ DE MD DC TX LA AK FL HI STATE MEDICAID DOES NOT COVER DPMs STATE MEDICAID COVERS DPMs SOURCE: American Podiatric Medical Association, March 2016

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9 Diverse Health-Care Stakeholder and Patient Advocacy Groups Endorsing the HELLPP Act: American Public Health Association Association for the Advancement of Wound Care California Medical Association Diabetes Advocacy Alliance * National Hispanic Medical Association Office and Professional Employees International Union Peripheral Arterial Disease Coalition Society for Vascular Surgery Vascular Disease Foundation * The following groups comprise the Diabetes Advocacy Alliance: Academy of Nutrition and Dietetics; American Association of Clinical Endocrinologists; American Association of Diabetes Educators; American Clinical Laboratory Association; American Diabetes Association; American Medical Association; American Optometric Association; American Podiatric Medical Association; Diabetes Hands Foundation Endocrine Society; Healthcare Leadership Council; National Association of Chain Drug Stores; National Association of Chronic Disease Directors; National Community Pharmacists Association; National Kidney Foundation; Novo Nordisk, Inc.; Omada Health; Pediatric Endocrine Society; Weight Watchers International, Inc.; YMCA of the USA; VSP Vision Care For copies of these letters of endorsement, please visit:

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11 The Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians Act 114th Congress Cosponsors (138): HR 1221 (127) S 626 (11) ALABAMA Rep Bradley Byrne (R) Rep Mike Rogers (R) ARKANSAS Sen Tom Cotton (R) Rep Rick Crawford (R) CALIFORNIA Rep Julia Brownley (D) Rep Ken Calvert (R) Rep Sam Farr (D) Rep John Garamendi (D) Rep Ted Lieu (D) Rep Zoe Lofgren (D) Rep Alan Lowenthal (D) Rep Doris Matsui (D) Rep Jerry McNerney (D) Rep Grace Napolitano (D) Rep Scott Peters (D) Rep Ed Royce (R) Rep Adam Schiff (D) Rep Jackie Speier (D) Rep Eric Swalwell (D) Rep Norma Torres (D) Rep Juan Vargas (D) Rep Maxine Waters (D) COLORADO Rep Diane DeGette (D) CONNECTICUT Rep Joe Courtney (D) Rep Rosa DeLauro (D) Rep Elizabeth Esty (D) Rep Jim Himes (D) Rep John Larson (D) DISTRICT OF COLUMBIA Del Eleanor Holmes Norton (D) FLORIDA Rep Corrine Brown (D) Rep Lois Frankel (D) Rep Alan Grayson (D) Rep Alcee Hastings (D) Rep David Jolly (R) Rep Ileana Ros-Lehtinen (R) Rep Debbie Wasserman Schultz (D) Rep Frederica Wilson (D) GEORGIA Rep Sanford Bishop (D) Rep Hank Johnson Jr. (D) Rep John Lewis (D) HAWAII Rep Mark Takai (D) ILLINOIS Rep Cheri Bustos (D) Rep Danny Davis (D) Rep Rodney Davis (R) Rep Tammy Duckworth (D) Rep Bill Foster (D) Rep Luis Gutierrez (D) Rep Robin Kelly (D) Rep Mike Quigley (D) Rep Bobby Rush (D) Rep Jan Schakowsky (D) Rep John Shimkus (R) INDIANA Rep Susan Brooks (R) Rep Pete Visclosky (D) Rep Jackie Walorski (R) IOWA Rep Rod Blum (R) Sen Joni Ernst (R) Sen Charles Grassley (R) Rep Steve King (R) Rep Dave Loebsack (D) Rep David Young (R) KENTUCKY Rep Brett Guthrie (R) Rep Hal Rogers (R) Rep Ed Whitfield (R) Rep John Yarmuth (D) LOUISIANA Rep Charles Boustany, Jr. (R) MARYLAND Rep C.A. Dutch Ruppersberger (D) Rep John Sarbanes (D) MASSACHUSETTS Rep Bill Keating (D) Rep Stephen Lynch (D) Rep Nicki Tsongas (D) MICHIGAN Rep Dan Benishek (R) Rep John Conyers (D) Rep Debbie Dingell (D) Rep Dan Kildee (D) Rep Brenda Lawrence (D) Rep Candice Miller (R) Rep John Moolenaar (R) Sen Gary Peters (D) Sen Debbie Stabenow (D) Rep Tim Walberg (R) MINNESOTA Rep Betty McCollum (D) Rep Collin Peterson (D) NEBRASKA Rep Brad Ashford (D) NEVADA Rep Joe Heck (R) Rep Dina Titus (D) NEW HAMPSHIRE Rep Ann McLane Kuster (D) Sen Jean Shaheen (D) NEW JERSEY Rep Frank LoBiondo (R) Rep Bill Pascrell (D) Rep Chris Smith (R) NEW MEXICO Rep Michelle Lujan Grisham (D) Sen Martin Heinrich (D) Sen Tom Udall (D) NEW YORK Rep Chris Collins (R) Rep Chris Gibson (R) Rep Steve Israel (D) Rep Peter King (R) Rep Charlie Rangel (D) Rep Kathleen Rice (D) Sen Charles Schumer (D) NORTH CAROLINA Rep Renee Ellmers (R) Rep Walter Jones (R) OHIO Rep Joyce Beatty (D) Sen Sherrod Brown (D) Rep Bill Johnson (R) Rep David Joyce (R) Rep Tim Ryan (D) Rep Steve Stivers (R) Rep Brad Wenstrup (R) OREGON Rep Earl Blumenauer (D) Rep Suzanne Bonamici (D) Rep Peter DeFazio (D) Sen Jeff Merkley (D) Rep Kurt Schrader (D) Rep Greg Walden (R) PENNSYLVANIA Rep Chaka Fattah (D) Rep Mike Kelly (R) Rep Patrick Meehan (R) RHODE ISLAND Rep Jim Langevin (D) TENNESSEE Rep Scott DesJarlais (R) Rep Chuck Fleischmann (R) Rep Phil Roe (R) TEXAS Rep Ruben Hinojosa (D) Rep Pete Olson (R) Rep Lamar Smith (R) UTAH Rep Rob Bishop (R) VIRGINIA Rep Barbara Comstock (R) Rep Gerry Connolly (D) Rep Randy Forbes (R) Rep Rob Wittman (R) WASHINGTON Rep Denny Heck (D) Rep Derek Kilmer (D) WISCONSIN Rep Ron Kind (D) Rep Gwen Moore (D) Rep Mark Pocan (D) Rep Reid Ribble (R) Rep Jim Sensenbrenner (R) Updated: May 2, 2016 (R) Republican (D) Democrat (I) Independent Energy & Commerce Committee Ways & Means Committee Senate Finance Committee Senate HELP Committee

12 B0 113 th Congress Cosponsors (135.): H.R (124) S (11) The Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians Act ALABAMA Rep Bradley Byrne (R) ARIZONA Rep Trent Franks (R) ARKANSAS Rep Rick Crawford (R) Sen Mark Pryor (D) CALIFORNIA Rep Julia Brownley (D) Rep Ken Calvert (R) Rep Tony Cardenas (D) Rep Sam Farr (D) Rep John Garamendi (D) Rep Zoe Lofgren (D) Rep Alan Lowenthal (D) Rep Doris Matsui (D) Rep Jerry McNerney (D) Rep Gloria Negrete McLeod (D) Rep Adam Schiff (D) Rep Jackie Speier (D) Rep Eric Swalwell (D) Rep Juan Vargas (D) Rep Maxine Waters (D) COLORADO Rep Diane DeGette (D) CONNECTICUT Rep Joe Courtney (D) Rep Rosa DeLauro (D) Rep James Himes (D) Rep John Larson (D) FLORIDA Rep Corrine Brown (D) Rep Lois Frankel (D) Rep Joe Garcia (D) Rep Alcee Hastings (D) Rep Bill Posey (R) Rep Ileana Ros-Lehtinen (R) Rep Steve Southerland (R) Rep Debbie Wasserman-Schultz (D) Rep Frederica Wilson (D) GEORGIA Rep John Barrow (D) Rep Sanford Bishop (D) Rep Hank Johnson (D) Rep David Scott (D) HAWAII Rep Colleen Hanabusa (D) ILLINOIS Rep Rodney Davis (R) Rep Tammy Duckworth (D) Rep William Enyart (D) Rep Luis Gutierrez (D) Rep Mike Quigley (D) Rep Bobby Rush (D) Rep Jan Schakowsky (D) INDIANA Rep Susan Brooks (R) Rep Jackie Walorski (R) IOWA Rep Bruce Braley (D) Sen Charles Grassley (R) Sen Tom Harkin (D) Rep Steve King (R) Rep Tom Latham (R) Rep Dave Loebsack (D) KANSAS Rep Lynn Jenkins (R) KENTUCKY Rep Brett Guthrie (R) Rep Harold Rogers (R) Rep Ed Whitfield (R) Rep John Yarmuth (D) LOUISIANA Rep Charles Boustany (R) MAINE Rep Michael Michaud (D) MARYLAND Sen Ben Cardin (D) Rep John Delaney (D) Rep C. A. Ruppersburger (D) Rep John P. Sarbanes (D) Rep Chris Van Hollen (D) MASSACHUSETTS Rep Stephen Lynch (D) Rep Niki Tsongas (D) MICHIGAN Rep John Dingell (D) Rep Dan Kildee (D) Rep Candice Miller (R) Rep Gary Peters (D) Sen Debbie Stabenow (D) Rep Tim Walberg (R) MINNESOTA Rep Michele Bachmann (R) Rep Betty McCollum (D) Rep Collin Peterson (D) MISSOURI Rep Wm. Lacy Clay (D) NEBRASKA Rep Lee Terry (R) NEVADA Rep Joseph Heck (R) Rep Steven Horsford (D) Rep Dina Titus (D) NEW JERSEY Rep Frank LoBiondo (R) NEW HAMPSHIRE Rep Ann Kuster (D) Sen Jean Shaheen (D) Rep Carol Shea-Porter (D) NEW MEXICO Rep Michelle Lujan Grisham (D) Sen Martin Heinrich (D) Rep Ben Ray Lujan (D) Sen Tom Udall (D) NEW YORK Rep Tim Bishop (D) Rep Chris Gibson (R) Rep Steve Israel (D) Rep Peter King (R) Sen Charles Schumer (D) Rep Louise Slaughter (D) Rep Paul Tonko (D) NORTH CAROLINA Rep G.K. Butterfield (D) Rep Renee Ellmers (R) Rep Patrick McHenry (R) OHIO Rep Joyce Beatty (D) Rep Bill Johnson (R) Rep Dave Joyce (R) Rep Marcy Kaptur (D) Rep Tim Ryan (D) Rep Steve Stivers (R) Rep Brad Wenstrup (R) OKLAHOMA Rep Jim Bridenstine (R) OREGON Rep Earl Blumenauer (D) Rep Suzanne Bonamici (D) Rep Peter DeFazio (D) Sen Jeff Merkley (D) Rep Kurt Schrader (D) Rep Greg Walden (R) PENNSYLVANIA Sen Robert Casey (D) Rep Mike Doyle (R) Rep Jim Gerlach (R) Rep Mike Kelly (R) SOUTH CAROLINA Rep Joe Wilson (R) TENNESSEE Rep Scott DesJarlais (R) Rep D. Phil Roe (R) TEXAS Rep Lloyd Doggett (D) Rep Ruben Hinojosa (D) UTAH Rep Rob Bishop (R) VIRGINIA Rep Gerald Connolly (D) Rep James Moran (D) Rep Robert Wittman (R) WASHINGTON Rep Denny Heck (D) Rep Derek Kilmer (D) Rep Cathy McMorris-Rogers (R) WISCONSIN Rep Ron Kind (D) Rep Gwen Moore (D) Rep Thomas Petri (R) Rep Mark Pocan (D) Rep Reid Ribble (R) Rep James Sensenbrenner (R) Updated December 16, 2014 (R) Republican (D) Democrat (I) Independent Energy & Commerce Committee Ways & Means Committee Senate Finance Committee Senate HELP Committee

13 Arizona Medicaid Study: Exclusion of Podiatric Physicians and Surgeons Adversely Impacted Diabetic Patient Health, Program Finances Arizona s decision to jettison Medicaid patient access to doctors of podiatric medicine (also referred to as DPMs, or podiatrists) has led to a marked worsening of outcomes and cost for patients with diabetic foot infections, according to a new peer-reviewed study released at the 73 rd Scientific Sessions of the American Diabetes Association (June, 2013). The study concludes that each $1 of Medicaid program savings the state anticipated from the elimination of podiatric medical and surgical services actually increased costs of care by $48. In Foot in Wallet Disease: Tripped up by "Cost Saving" Reductions, researchers Grant H. Skrepnek, PhD, RPh, Joseph L. Mills, MD, and David G. Armstrong, DPM, MD, PhD, analyzed data for all Medicaid diabetic foot infection hospital admissions across the state over five years ( ), a time period before and after the state s decision in 2009 to exclude DPMs from its Medicaid program. The study found a significant decline in quality outcomes and higher program expenditures among those diagnosed with a diabetic foot infection, including: 37.5-percent increase in diabetic foot infection hospital admissions; 28.9-percent longer lengths of patient stay; 45.2-percent higher charges, and a nearly 50-percent increase in severe aggregate outcomes (e.g., death, amputation, sepsis, or surgical complications). Importantly, the data reveal that the vast majority of the worsening of diabetic foot infection patient health outcomes and increased costs occurred during the time window, coinciding with Arizona s policy change to exclude patient access to foot and ankle care provided by DPMs. Inpatient Diabetic Foot Infections among Arizona Medicaid Beneficiaries Percent Change from Baseline, Six-Month Moving Average Timepoint A: Announced recommendation to eliminate reimbursements to podiatrists within Arizona Health Care Cost Containment System, AHCCCS (i.e., Arizona Medicaid); Arizona 49 th Legislature SB 1003 and HB 2003[OCTOBER 2009] Timepoint B: Arizona 49th Legislature SB 1003 and HB 2003 legislation signed [MARCH 2010] Timepoint C: Official date of podiatric service coverage elimination [JUNE 2010]

14 Policy Implications for Modernizing Medicaid Arizona s Medicaid experience underscores the compelling policy rationale for removing patient access barriers to podiatric physicians and surgeons. The Arizona study complements two additional, separate studies that found that when podiatrists are administering medical and surgical foot and ankle care, outcomes are better, hospitalizations are fewer and shorter, and the health-care system saves billions of dollars annually. 1 The unfortunate counterproductive experience that embroiled Arizona is also happening in other states around the country. The core problem persists because podiatrists are not defined as physicians under Medicaid, even though they have been defined as such under Medicare for more than 40 years and are recognized as such throughout most of the US health-care system. Doctors of podiatric medicine prescribe medication, perform surgeries, and are licensed by their state boards to deliver independent medical and surgical care 1 The Economic Value of Specialized Lower- Extremity Medical Care by Podiatric Physicians in the Treatment of Diabetic Foot Ulcers, Journal of the American Podiatric Medical Association, Vol. 101, No 2, March/April, 2011; and Sloan, F.A., Feinglos, M.N. and Grossman, D.S., RESEARCH ARTICLE: Receipt of Care and Reduction of Lower Extremity Amputations in a Nationally Representative Sample of U.S. Elderly. Health Services Research, no. doi: /j x Details of both studies accessible at: Fact Sheet: Studies Prove Podiatrists Prevent Complications, Provide Savings without any supervision or collaboration requirement. Ironically, Medicaid only ensures coverage of necessary foot and ankle care if provided by a medical doctor (MD) or a Doctor of Osteopathy (DO). But Medicaid coverage for foot and ankle care provided by DPMs is optional for states, meaning podiatry services are teased out and classified as an optional benefit. Under current law, states are under constant pressures to curtail optional services like patient access to podiatrists in a penny wise/pound foolish attempt to trim Medicaid budgets. But as this Arizona Medicaid study indicates, doing away with podiatry services is a classic demonstration of the law of unintended consequences. A Common-Sense, Bipartisan Solution to Provide Cost Savings to Medicaid Unnecessarily higher Medicaid spending by states also translates to unnecessarily higher spending by the federal government, because Medicaid is financed jointly by the federal government and the states. The federal government matches state Medicaid spending. To address this long-standing counterproductive state churning of optional access to podiatric physicians and surgeons, US Representatives Renee Ellmers (R-NC) and Diana DeGette (D-CO), and US Senators Chuck Grassley (R-IA) and Charles Schumer (D-NY) have introduced the Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act (HR 1221 / S 626). This bipartisan legislation would help modernize and strengthen

15 Medicaid by recognizing, at long last, podiatrists as physicians under Medicaid, thereby enhancing patient choices and access, and improving health outcomes for those in need of specialized foot and ankle care. The bill also would improve aspects of care coordination in Medicare s diabetic shoe program, and strengthen Medicaid program integrity by offsetting government reimbursements for any unpaid federal taxes owed by health providers with prolonged federal tax delinquency issues. As Arizona Medicaid has shown, maintaining a separate optional podiatry benefit has had significant negative health effects on patients with diabetes. State (and by extension, federal) Medicaid spending is not reduced, but merely redistributed to another setting or provider, often with adverse consequences for patient health and health costs. The current ever-changing patchwork of Medicaid patient access has the effect of limiting access to timely and appropriate foot and ankle care, at a time when the US is already facing a growing physician shortage. So long as our public policy focus is on the type of provider rendering foot and ankle care, instead of ensuring the coverage of medically necessary foot and ankle care, preventable chronic conditions will become an even greater cost burden for Medicaid. In virtually all other health-care settings Medicare, private employer coverage, Federal Employees Health Benefits (FEHBP), TRICARE, the Veterans Administration, and the Indian Health Service patient access to specialized podiatric medical and surgical care is ensured. Medicaid is the glaring exception. As Congress considers options to modernize and strengthen the Medicare and Medicaid programs, the provisions of the commonsense, bipartisan HELLPP Act should be part of any discussion. The legislation represents a sound policy rationale in making the commitment to ensure timely patient access to specialty medical and surgical foot and ankle care.

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17 ISSUE BRIEF CBO Should Revisit Cost Estimate of The Helping Ensure Lifeand Limb-Saving Acess to Podiatric Physicians (HELLPP) Act The Congressional Budget Office (CBO) prepared a cost estimate of S. 1871, the SGR Repeal and Medicare Beneficiary Improvement Act of 2013, as reported by the Senate Finance Committee on January 16, 2014 which included two provisions related to podiatric physicians (Sec. 254). The American Podiatric Medical Association (APMA) takes strong exception to CBO s budgetary impact estimate of Section 254, provisions from the Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act, and urges CBO to review the provisions and APMA s supporting documentation. The CBO estimate states that: Section 254 would promote Medicaid beneficiary access to podiatrists and expand Medicare coverage of therapeutic shoes for beneficiaries with diabetes. CBO estimates that those changes would increase direct spending by about $1 billion between 2014 and CBO acknowledges that: Because Medicaid provides states with significant flexibility to make programmatic adjustments in response to such changes in requirements, the [requirement to include podiatrists as physicians under the Medicaid program] would not be [an] intergovernmental mandate as defined in UMRA [the Unfunded Mandates Reform Act]. APMA believes the HELLPP Act provisions warrant a closer look by the CBO. The estimate incorrectly describes the Medicare provision as expanding coverage. On the contrary, the Medicare provision of the HELLPP Act is a paperwork clarification of the current Medicare benefit to better account for how medical professionals certify, prescribe, dispense services, and maintain records under the Medicare diabetic shoe benefit. Underscoring this point, a rule of construction has been incorporated into the current version of the HELLPP Act clarifying that the legislative lanuguage should not be constured as expanding coverage under the Medicare diabetic shoe program. APMA also believes the federal budgetary impact of defining podiatrists as physicians under Medicaid should be significantly lower than what CBO recently estimated. In fact, in 2009, CBO reviewed the very same provision in the context of a much broader Medicaid expansion proposal and estimated it would cost $200 million over 10 years. However CBO s recent estimate inexplicably inflated its previous estimate even in light of the following changes to the Medicaid landscape since then: Medicaid expansion population is smaller. The Affordable Care Act (ACA) expands coverage to only 133% of the Federal Poverty Level (FPL), while the 2009 legislation CBO was analyzing called for Medicaid expansion for a larger population of up to 150% FPL. Medicaid expansion under the ACA is optional as determined by Supreme Court ruling. CBO estimated that the ruling would cause 6 million fewer people to be enrolled in Medicaid and would reduce overall Medicaid spending by $289 billion over 10 years. Numerous peer-reviewed studies demonstrate that care by podiatrists improves patient outcomes and reduces hospitalizations, saving the health-care system from significant unnecessary costs. Understanding CBO may not revisit and revise its estimate, the HELLPP Act includes a provision to offset any increased spending by closing a loophole so that Medicaid payments to tax-delinquent Medicaid providers would be reduced by the amount of federal taxes that are owed. Such a mechanism already exists in Medicare and is supported by a Government Accountability Office (GAO) study highlighting this irregularity, released July, 2012 (GAO ): Providers in Three States with Unpaid Federal Taxes Received over $6 Billion in Medicaid Reimbursements. CBO Should Revisit Cost Estimate of The HELLPP Act Prepared by the American Podiatric Medical Association, 9312 Old Georgetown Road, Bethesda, MD 20814, , Contact advocacy@apma.org with questions.

18

19 Fact Sheet: Strengthening Medicaid Program Integrity Budget Savings in the Bipartisan HELLPP Act (HR 1221 / S 626) The bipartisan Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act (HR 1221 / S 626) would enhance patient access to podiatric physicians and surgeons and improve quality outcomes by recognizing doctors of podiatric medicine (DPMs) as physicians under Medicaid, and removing regulatory inconsistencies and confusion in Medicare s diabetic shoe program. The bill would also strengthen Medicaid program integrity and provide federal budget savings through a common-sense reform recommended by the US Government Accountability Office (GAO) in its July 2012 report: Providers in Three States with Unpaid Federal Taxes Received over $6 Billion in Medicaid Reimbursements (July 2012, GAO ). THE PROBLEM: Health-care providers who owe significant back taxes for years may still receive full Medicaid payments because of a loophole in the tax laws. Under Medicare and most federal programs, the Internal Revenue Service can garnish, or offset, federal payments when a health-care provider has an unpaid tax bill, but Medicaid s state-based system has prevented its payments from qualifying as a federal payment. The GAO responded to a bipartisan senate request regarding this anomaly and found that for the 7,000 delinquent Medicaid providers we identified in three states (Florida, New York and Texas), if there had been such an automated continuous levy system in place [similar to what exists in Medicare], we estimate that between $22 million and $330 million could have been collected to offset unpaid federal taxes in FEDERAL PAYMENT LEVY PROGRAM: Through the Federal Payment Levy Program, established in July 2000, the IRS can collect overdue taxes through a continuous levy on certain Federal payments; this includes Medicare fee-for-service payments. This levy is continuous until the overdue taxes are paid in full, or other arrangements are made to satisfy the debt. As of February 15, 2013, the Centers for Medicare and Medicaid Services (CMS) has realized a cumulative total of over $193 million in tax levy offsets. HELLPP ACT BUDGET SAVINGS: The HELLPP Act includes a provision to close this tax loophole, allowing for improved collection of outstanding tax debts from Medicaid providers. The provision which has been offered in several bipartisan bills in the past would add Medicaid to the definition of federal payment, thereby extending the federal government s continuous levy mechanism to cover payments to Medicaid providers or suppliers. If such a program integrity mechanism could be used in Medicaid similar to the way it is used in Medicare, GAO estimates that between $22 million and $330 million in owed unpaid federal taxes could have been collected in the selected three states in 2009.

20 American Medical News / amednews.com Tax delinquents still drawing Medicaid pay, GAO reports At least 7,000 health care professionals in three states received more than $6 billion in total Medicaid payments despite owing back taxes. By Jennifer Lubell amednews staff Posted Aug. 10, 2012 Print Respond Reprints Like Share Tweet Washington Health care professionals who owe significant back taxes for years still are getting paid by Medicaid because of a loophole in the tax laws, the Government Accountability Office concluded in a report issued Aug. 2. GAO investigated known federal tax debts owed by Medicaid health care professionals in Florida, New York and Texas three states whose Medicaid programs received some of the largest allotments of money from the 2009 federal stimulus package. The agency found that roughly 7,000 were delinquent on nearly $800 million in federal taxes from 2009 or earlier but had been paid a total of more than $6 billion by Medicaid. Because the estimates didn t include entities that either had underreported their income or failed to file tax returns, the watchdog agency expects that the amount of unpaid taxes was even higher. The report also profiled 40 Medicaid health care professionals or businesses that had sizable federal tax debts in these states. GAO found that they collectively had received a total of $235 million in pay in 2009 even though they owed nearly $26 million in taxes to the federal government through Physicians, dentists, hospitals, home care providers, durable medical equipment suppliers and social services providers were among those represented in this case study. Some of these entities, which were not identified by name in the report, had been associated with potential criminal activity or abuse of the federal tax system, according to GAO. The people profiled are tax cheats, said Sen. Tom Coburn, MD (R, Okla.), the lead Republican on the Senate Homeland Security and Governmental Affairs Permanent Subcommittee on Investigations. GAO s findings underscore a need to raise the integrity of the Medicaid program, said Dr. Coburn, who requested the report along with other leaders on the committee and the Senate Finance panel. It s unfortunate that this much was identified as unpaid taxes, because that s revenue that could provide care to people, said Glen Stream, MD, president of the American Academy of 2

21 Family Physicians. We expect people to be good citizens and pay their taxes, including physicians. But because Medicaid doesn t pay very well, Dr. Stream suggested that some of the tax delinquency might involve practices being in a state of financial distress. While this isn t an excuse, he said, there may be more understandable reasons than egregious financial behavior. The Internal Revenue Service can garnish federal payments when the recipient has an unpaid tax bill, but Medicaid s state-based system has kept its pay from qualifying as a federal payment. IRS currently may only subject Medicaid reimbursements to a one-time levy instead of a continuous levy, GAO stated. The report cited an example of a physician who had received more than $200,000 in Medicaid pay but owed more than $500,000 in unpaid federal taxes. The IRS ended up having little success in placing a levy on this physician s Medicaid payments. GAO estimates that the IRS could have recouped up to $330 million in these three states if it had been able to issue continuous levies on Medicaid payments. But given the difficulties they face just in processing one-time levies, state officials interviewed by GAO expressed doubts about using continuous levies. GAO has investigated similar problems in the Medicare program. In 2007, the agency reported that 21,000 physicians in 2005 had been paid by the program despite owing a total of more than $1 billion in back payroll and income taxes. The most recent report can be viewed online (link). 3

22

23 Clarifying and Strengthening Coordination of Care in the Medicare Diabetic Shoe Program ISSUE BRIEF In order for a patient to be eligible for Medicare s Diabetic Shoe Program, a physician (MD or DO) must certify that the patient has diabetes mellitus, that the patient is being treated under a comprehensive plan of care for diabetes, and that it would be medically necessary for the diabetic patient to have therapeutic diabetic shoes. The MD or DO physician who is treating the patient s systemic diabetes condition must currently also certify that the patient qualifies at least one of six lower extremity conditional findings for diabetic shoes/inserts eligibility: a. Previous amputation of the other foot, or part of either foot; or b. History of previous foot ulceration of either foot; or c. History of pre-ulcerative calluses of either foot; or d. Peripheral neuropathy with evidence of callus formation of either foot; or e. Foot deformity of either foot; or f. Poor circulation in either foot. In practice, a podiatrist a doctor of podiatric medicine (DPM) or an orthopedist, is the one who performs the patient s detailed lower extremity examination qualifying at least one of these six conditional findings. In doing so, it is the podiatrist or orthopedist who typically identifies medical necessity (and writes the prescription/order for diabetic shoes/inserts) and initiates contact with and reports requisite information to the patient s physician (e.g., the certifying MD/DO). Podiatrists/orthopedists are finding that their medical records, which contain more detailed lower extremity examination findings than the MD/DO s records, are either being discounted or completely ignored by the DME Medicare Administrative Contractors (DMACs), Contractor Medical Directors, and auditors when records are submitted for qualifying their patient for the therapeutic shoe and insert benefit. Refunds are being asked from the suppliers (both podiatrist-suppliers and commercial suppliers). Recent rates of audit claims error/denials are alarmingly high. Some recent reviews reveal 85% to 97% of the audited claim submissions are being denied by regulators and auditors who have been following narrow DMAC Local Coverage Determination policies. (APMA has received anecdotal evidence that a large number of these decisions are being overturned favorably by administrative law judges.) For several years, APMA has discussed these problems with CMS and the DMACs, and while they are sympathetic, they have said that any remedy must come from a statutory change. APMA members are becoming increasingly frustrated with this status quo, with a number now dropping their participation in the Medicare Diabetic Shoe Program and many others considering no longer serving as suppliers. The anticipated consequences include reduced or progressively difficult access to this medically necessary and appropriate benefit for diabetic patients. APMA has identified some minor balanced improvements to clarify provider roles and remove confusion and regulatory inconsistencies in the provision of this medically necessary benefit. These clarifications would preserve the integrity of the checks and balances in the diabetic shoe/ insert program. MDs or DOs who are treating the patient s diabetes would certify that the patient is under a comprehensive program of management of the disease; podiatrists/orthopedists would determine medical necessity for diabetic therapeutic shoes and inserts and prescribe those shoes and inserts; suppliers would fit, provide, and evaluate fit of the shoes and inserts. Under this proposal, the roles of the MD, DO, and DPM would, however, be clarified, thereby strengthening their coordination of care and communication in treating Medicare diabetic patients. These targeted reforms would amend 1861(s)(12) of the Social Security Act to clarify roles and improve communications among medical providers. They will significantly reduce the frustrations of the physicians and suppliers over the current administrative policies of the Medicare Diabetic Shoe Program, help ensure that those Medicare patients who are most at risk and eligible for this benefit receive it, and obviate Medicare diabetic patients making additional office visits, which in turn would save money for patients/ beneficiaries and the Medicare program. Clarifying and Strengthening Coordination of Care in the Medicare Diabetic Shoe Program Prepared by the American Podiatric Medical Association, 9312 Old Georgetown Road, Bethesda, MD 20814, , Contact advocacy@apma.org with questions.

24 FOOTWEAR MATTERS Foot problems associated with diabetes are a signifcant portion of the health risk and cost. IMPAIRED SENSATION OR FOOT PAIN RISK OF AMPUTATIONS HIGH COSTS FOR FOOT ULCER CARE 60 % -70 % of diabetes patients have mild to severe forms of nervous system damage CAN CAUSE impaired sensation or pain in the feet 1 of all lower limb amputations in the U.S. result from diabetes 2 80 % of these amputations 67 % were preceded by a foot ulcer COSTS COSTS TIMES HIGHER FIRST YEAR TIMES HIGHER SECOND YEAR AFTER FIRST FOOT ULCER Compared with diabetic patients without foot ulcers 3 1 Center for Diseases Control (CDC) National Diabetes Fact Sheaet, The costs of diabetic foot: The economic case for the limb salvage team. Journal of Vascular Surgery 2010;52:17S-22S; Reiber G. Epidemiology and Health Care Costs for Diabetic Foot Problems. In: Veves A, Giurini J, LoGerfo F, eds. Diabetic Foot: Medical and Surgical Treatment. Totowa, NJ: Humana Press; 2002; The costs of diabetic foot: The economic case for the limb salvage team; Boston, Mass; and Georgetown, Tex. Therapeutic footwear can decrease ulcers and amputations in diabetic patients For many diabetes patients, not wearing therapeutic footwear isn t worth the risk. FOOT CARE PROGRAMS THERAPEUTIC FOOTWEAR CUSTOM ORTHOTIC INSOLES AMPUTATIONS FOOT ULCERS AMPUTATIONS FOOT REULCERATIONS AMPUTATIONS LOWERED UP TO 85 % Programs include: Risk assessment Foot-care education and preventive therapy Treatment of foot problems Referral to specialists 1 LOWERED 12 % AFTER 2 YEARS LOWERED 18 % Examined the impact of therapeutic footwear on diabetic complications (foot ulcers and amputations) Patients with Type 2 Diabetes mellitus (T2DM) Sample size = 26,437 people Compared same patient, pre and post therapeautic footwear usage Followed patients for 1 year before and 2 years after receiving therapeutic shoes 4 LOWERED TO 15 % AFTER 2 YEARS LOWERED TO 6 % 79% reulceration rate before treatment 54% amputation rate before treatment 5 4 Minshall ME, Durden E, Huse DM, McMorrow D, Lidtke RH. Characteristics and Health Care Resource Utilization of Type 2 Diabetes Mellitus (T2DM) Patients Using Therapeutic Footwear. Diabetes, 2014; 63(Suppl. 1): A How Effective Is Orthotic Treatment in Patients with Recurrent Diabetic Foot Ulcers? Journal of the American Podiatric Medical Association 2013;103:

25 9312 Old Georgetown Road Bethesda, MD Tel: Fax: Clarifying and Strengthening Coordination of Care in the Medicare Diabetic Shoe Program The Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act (HR 1221 / S 626) contains a provision to remove regulatory inconsistencies and provider confusion in Medicare s Therapeutic Shoes for Diabetics program, thereby enabling providers to work more efficiently and seamlessly on behalf of the patients they serve. Recent data from two DME Medicare Administrative Contractors strongly suggest a flawed and confusing process in the provision of Medicare diabetic shoes, and underscore the need for clarifications like the ones contained in the HELLPP Act. Initial Claims Processing Region C (CIGNA Government Services) Q Region D (Noridian) Denial Rate 80% 82% Common Reasons for Denial 1) Medical records from the certifying physician were not provided. (40%) 2) The clinician foot examination was performed by a clinician (another physician, podiatrist, nurse practitioner, clinical nurse specialist, physician assistant) other than the certifying physician and the certifying physician did not signify that he/she reviewed and agreed with the exam findings by stating approval and signing and dating the examination notes. (32%) ** 3) Documentation did not include a clinical foot exam. (13%) 4) The supplier's in-person evaluation of the beneficiary's feet was missing one or both of the following required elements: (1) Description of the abnormalities the shoes/inserts/modification need to accommodate; or (2) Measurements of the beneficiary's feet. (12%) 5) Documentation provided by the supplier did not include a copy of a detailed written order. (12%) 1) Documentation of foot abnormalities by certifying physician not met 2) Documentation of diabetes management by certifying physician not met 3) No documentation was received 4) Documentation of in-person visit prior to selection of items not met

26 American Podiatric Medical Association, Inc. Error rates are generally calculated by reviewing each claim and determining if there was an error in any of the following, for example: Does the item/equipment fit a Medicare benefit category? Is the item/equipment statutorily excluded? Is the item/equipment medically reasonable and necessary? Is there documentation to support that the item/equipment was provided? Was the item/equipment coded and billed correctly? Error rates of 80% or higher should be a concern to policymakers that either the review criteria is unclear or that the claims adjudication process itself is flawed. These error rates remain consistently high across the most recent quarters available (in excess of 75%). ** The HELLPP Act would significantly improve some exceedingly high error rates by addressing Reason 2 under CIGNA (present in 32% of denials) and potentially Reason 1 under Noridian (percentages not available). 2

27 Medicare s Therapeutic Shoe Program: Problems Patient makes a minimum of one additional E/M office visit 2 1 Prescribing Physician: Podiatrist (DPM) or orthopedist (MD/DO) sees and examines patient; patient sent back to their MD/DO with a prescription for therapeutic shoes/inserts. Majority of podiatrist s or orthopedist s lower extremity examination records are shared with the certifying MD/DO MD/DO Certifying Physician: manager of patient s diabetes MD/DO sends supplier completed statement of certification, a copy of their medical record with evidence of ongoing management of the patient s diabetes and an MD/DO signed copy of the prescribing physician s lower extremity examination validating the presence of at least one of the 6 possible lower extremity findings Supplier (either a commercial supplier or the prescribing physician) Overview of Process 1. DPM or orthopedist performs lower extremity evaluation, determines patient has one or more of 6 conditions, writes prescription for diabetic shoe(s). 2. Refers patient back to MD/DO managing diabetes. The prescribing physician forwards the prescription for the therapeutic shoes/inserts to the supplier as well as a copy of their medical record examination, information about the therapeutic shoe program, instructions for the certifying doctor, and the statement of certification form. Patient makes a minimum of one additional E/M office visit to complete the examination and certifying requirements, going BACK to the primary care physician because medical necessity and clinical findings of prescribing doctor are not recognized as valid by program auditors. 3. Medical records by DPM/orthopedist are not accepted as being valid or even complementary to managing physician s findings of medical necessity. Only physician managing diabetes can make medical necessity determination qualifying for therapeutic shoes. And their clinical findings are often incomplete. 4. Often suppliers are finding payments for therapeutic shoes/inserts could be denied or be retracted because of MD/DO medical documentation is incomplete. 5. If the prescribing physician (e.g., DPM or orthopedists) is not the supplier, likely 2 additional E/M services to be billed. SUMMARY: Significant problems result in delayed patient care, increased patient and provider frustration, and unnecessarily higher Medicare expenditures. 3 4 Often material received from the certifying physician is missing or incomplete, causing payments to suppliers to be denied or retracted

28 Medicare s Therapeutic Shoe Program: Solution MD/DO Certifying Physician: manager of patient s diabetes evaluates patient, confirms management of diabetes, communicates with prescribing physician, agrees to the medical necessity of therapeutic shoes/inserts; and fills out the necessary paperwork for the supplier 3 Doctor of Podiatric Medicine (DPM) / Orthopedist (MD/DO) Prescribing Physician: evaluates patient, determines medical necessity, prescribes the appropriate therapeutic shoes and inserts, and communicates with the certifying physician The prescribing physician forwards both the prescription and relevant patient medical records to the supplier Supplier (either a commercial supplier or the prescribing physician) Overview of Process 1. The prescribing physician (e.g., DPM or orthopedist) examines the patient, determines medical necessity, writes a prescription for the appropriate therapeutic shoes/inserts, and refers the patient to the supplier (either a commercial supplier or the prescribing physician [who may also act as supplier]). 2. The prescribing physician shares his/her patient medical records with the certifying physician along with relevant forms and instructions for the certifying physician on the therapeutic shoe program requirements. 3. The certifying physician (MD/DO) reviews his/her patient medical record, as well as the prescribing physician s medical record, and agrees with the medical necessity for the therapeutic shoes/inserts. The certifying physician may attest to medical necessity or may call for additional patient visit. Forwards a completed statement of certification and copies of the relevant medical record to the supplier. The prescribing physician shares patient medical records with certifying physician and forwards the prescription for the appropriate therapeutic shoes/inserts and relevant medical record to the supplier. The supplier proceeds fitting and furnishing the prescribed shoes/inserts once all the required and appropriate paperwork is received. Reform Summary o o Reforms clarify that patient does not need a certifying physician visit to establish if a patient can be seen by the prescribing physician; the prescribing physician (the lower extremity specialist) is already treating the patient and their his/her records can optionally serve as evidence of clinical lower limb qualification; the certifying physician must agree (checks and balance) to the medical necessity of the therapeutic shoes; and there is a maintenance that the certifying physician (MD/DO) is the only party that can qualify the statement of certification. Reforms clarify that additional patient office visits to certifying physician are not required but are up to the certifying physician s discretion if necessary. Reforms eliminate unnecessary steps extra visits confusion, and frustration over the administration of this program. Wasted time and unnecessary spending are eliminated. Fraud and abuse program safeguards remain in place.

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